NCT05310383

Brief Summary

This study is a prospective, multicenter, phase II clinical trial to evaluate the efficacy and safety of albumin-bound paclitaxel plus bevacizumab for platinum-resistant recurrent epithelial ovarian cancer. Patients with platinum-resistant recurrent ovarian cancer who meet the inclusion criteria, and don't meet any of the exclusion criteria, are enrolled in the study. They will receive albumin-bound paclitaxel (260 mg/m2) and bevacizumab (7.5mg/kg) intravenously every 21 days. The total treatment periods are no more than 6 cycles. Treatment continue until disease progression, intolerable toxicity, or patient refusal. Objective response rates primary objective. Progression-free survival, overall survival, and safety are secondary objectives. The study will enroll a total of 50 patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

March 27, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2024

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

1 year

First QC Date

March 26, 2022

Last Update Submit

April 1, 2022

Conditions

Recurrent Cervical CarcinomaMetastatic Cervical CarcinomaPersistent Cervical CarcinomaRadiotherapyImmunotherapyAnti-programmed Cell Death Receptor 1Immune Checkpoint InhibitorsTislelizumabObjective Response RateSurvival Outcomes

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate

    Overall survival is defined as the duration from date of enrollment to the date of death from any cause

    12 months

Secondary Outcomes (3)

  • Progression-free survival (PFS)

    12 months

  • Overall survival

    24 months

  • Adverse Events

    24 months

Study Arms (1)

Patients with recurrent cervical cancer

EXPERIMENTAL

Patients with recurrent, metastatic and persistent advanced cervical cancer

Combination Product: Tislelizumab plus radiotherapy

Interventions

Tislelizumab plus radiotherapyCOMBINATION_PRODUCT

During the period of radiotherapy, patients receiveTislelizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W). Tislelizumab 200mg q3W was administered for up to 35 cycles (up to approximately 2 years) after radiotherapy until disease progression or toxicity.

Patients with recurrent cervical cancer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient voluntarily participates and signs informed consent
  • Aged 18 years of age or older
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 within 7 days prior to the first dose of study treatment
  • Has recurrent cervical cancer and controllable local treatment, indicating an indication for radiation therapy
  • Willing to accept concurrent radiotherapy combined with Tislelizumab
  • Has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the local investigator
  • Has adequate organ function
  • Has expected survival time ≥3 months

You may not qualify if:

  • Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
  • Has a known history of Human Immunodeficiency Virus (HIV) infection，active Hepatitis virus infection and active tuberculosis (TB; Bacillus tuberculosis)
  • Has known active central nervous system (CNS) metastases and/or uncontrolled, untreated carcinomatous meningitis with elevated intracranial pressure
  • Has received a major surgery within 4 weeks prior to signing informed consent
  • Not suitable for radiotherapy
  • Reassessment of liver and kidney function and blood routine indexes after radiotherapy did not meet the above criteria
  • Judged unqualified of the enrollment requirements by the researcher according to other conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

tislelizumabRadiotherapy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Lei Li, M.D.

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, M.D.

CONTACT

86-139-1198-8831lileigh@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 26, 2022

First Posted

April 4, 2022

Study Start

March 27, 2022

Primary Completion

March 27, 2023

Study Completion

March 27, 2024

Last Updated

April 11, 2022

Record last verified: 2022-04

Locations

CN(1)